Issues in Global Simultaneous Development

Kihito Takahashi MD

The 3rd KH-Symposium 3 Oct. 2002

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Japanese-specific Issues in the International Studies

• How many patients is enough from Japan?

• Ethnicity sub-analysis necessary ? The study is powered based on the total number of su

bjects Meaning of strictly pre-defined similarity criteria betw

een Japanese and others in race subanalysis

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Challenges in International Studies

• Data management standards

• IT system integration

• Data quality

• Language

• Regulatory practice and requirements

• Global study management

• Clinical study report development